ICER will develop a report on anti-androgen drugs for high risk prostate cancer. The report is expected to include enzalutamide (Xtandi®, Astellas and Medivation), abiraterone acetate (Zytiga®, Janssen), apalutamide (Erleada™, Janssen).
- September 2009: Active surveillance and Radical prostatectomy
- December 2008: Brachytherapy and Proton beam therapy
Proton beam therapy was also the subject of an evidence review by ICER for the Washington State Health Care Authority in May 2014.
- November 2007: Intensity modulated radiation therapy (IMRT)
ICER will review new therapies for the treatment of hereditary transthyretin-related (hATTR) amyloidosis, a rare genetic condition characterized by nerve, heart, and eye damage that is currently treated through supportive measures alone.
The review is expected to include inotersen (Ionis Pharmaceuticals, Inc.), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway. Approvals are expected in October and August of 2018, respectively.
ICER will assess the comparative clinical effectiveness and value of therapies for hereditary angioedema, a rare condition characterized by attacks of deep tissue swelling within the skin and/or mucosa. The report is expected to focus on four therapies for the prevention of hereditary angioedema attacks: lanadelumab (Shire), which is currently under review by the FDA with an approval decision expected in August of 2018, and three C1 esterase inhibitors (Haegarda®, CSL Behring; Cinryze®, Shire; and Ruconest®, Pharming). This list is tentative and subject to change.
Opioid use disorder has reached a critical level in the United States, driven by over-prescription and diversion of opioid painkillers, as well as the low cost and increased potency of heroin. The societal impact is substantial in terms of costs related to treatment, lost work productivity, criminal activity, and social welfare expenditure. The goals of treatment for opioid use disorder include a decrease in illicit opioid use, decreased mortality, and reductions in criminal activity.
Interventions of interest, 2018 review:
Medications for addiction treatment using:
- Monthly buprenorphine injection (Sublocade™, Indivior)
- Buprenorphine implant (Probuphine®, Braeburn/Titan)
- Buprenorphine extended release injection (CAM2038, Braeburn) currently under review by the FDA
These therapies will be compared to MAT with methadone, buprenorphine/naloxone sublingual film (Suboxone®, Indivior), and injectable naltrexone (Vivitrol®, Alkermes).
A 2014 review assessed MAT with methadone or buprenorphine-containing agents (Subutex®, Reckitt Benckiser Pharmaceuticals Inc.; Suboxone®, Indivior Inc.); dose-tapering strategies for methadone or Suboxone, with or without naltrexone (Revia®, Duramed Pharmaceuticals, Inc.; Vivitrol®, Alkermes, Inc.); use of naltrexone alone without prior stabilization on methadone or buprenorphine; and drug-free opioid withdrawal management.
An estimated 22 million Americans have asthma, which causes the airways of the lungs to narrow or become blocked, making it hard to breathe. Among both young and old, asthma can have a significant impact on health and limit the ability to pursue many activities.
Interventions of Interest, 2018 review: Dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra™, AstraZeneca)
Intervention of interest, 2016 review: Mepolizumab (Nucala®, GlaxoSmithKline plc.)
ICER will review the comparative clinical effectiveness and value of canakinumab (Novartis) for cardiovascular risk reduction in people with atherosclerosis.
ICER will develop a report assessing the comparative clinical effectiveness and value of AVXS-101 (Novartis) and nusinersen (Spinraza®, Biogen) for treatment of spinal muscular atrophy (SMA).
Plaque psoriasis is a common disease that causes red, scaly, raised lesions on the skin, most commonly on the elbows, knees, scalp, and back. Psoriasis affects about 2% of the population and significantly decreases health-related quality of life. It is a chronic inflammatory condition associated with systemic diseases.
Interventions of interest:
- Anti TNF agents: Adalimumab (Humira®, AbbVie), etanercept (Enbrel®, Amgen, Inc.), infliximab (Remicade®, Janssen)
- Anti IL-17A agents: Secukinumab (Cosentyx®, Novartis), ixekizumab (Taltz®, Eli Lilly and Co.), brodalumab (SiliqTM, Valeant Pharmaceuticals and AstraZeneca)
- Anti IL-12/23 agent: Ustekinumab (Stelara®, Janssen)
- Anti PDE4 agent: Apremilast (Otezla®, Celgene)
Included in planned 2018 Condition Update:
- Anti IL-23 agents: Guselkumab (Tremfya®, Janssen/Johnson & Johnson), tildrakizumab (Sun Pharma), risankizumab (AbbVie)
- Anti TNF agent: Certolizumab pegol (Cimzia®, UCB)
Migraine is a common, recurrent headache disorder and is among the top ten causes of years lived with disability in the US. Someone experiencing a migraine episode may feel moderate-to-severe pain and other symptoms (e.g., nausea, vomiting, or sensitivity to light or to sound), have a reduced ability to function, or require bed rest. Despite its high prevalence and impairment, migraine is often not recognized or effectively treated.
Interventions of interest, July 2018 review:
- Erenumab (Amgen/Novartis)
- Fremanezumab (Teva)
- Galcanezumab (Eli Lilly)
Interventions of interest, July 2014 review:
- OnabotulinumtoxinA (Botox®, Allergan, Inc)
- Transcutaneous electrical nerve stimulation (Cefaly®, Cefaly Technology)
- Single pulse transcranial magnetic stimulation (SpringTMS™, eNeura Inc.)
Cystic fibrosis is an autosomal recessive condition caused by mutations in the CFTR gene. It is relatively rare, occurring in approximately 1 in 2,500 to 3,000 livebirths, but is the most common, lethal genetic disease in Caucasian populations. CF is a progressive disease that affects many organ systems, but most of its morbidity and mortality are associated with its impact on the respiratory system.
Interventions of Interest:
- Tezacaftor/ivacaftor (SymdekoTM, Vertex Pharmaceuticals)
- Lumacaftor/ivacaftor (Orkambi®, Vertex Pharmaceuticals)
- Ivacaftor (Kalydeco®, Vertex Pharmaceuticals)
The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emicizumab (Hemlibra®, Genentech), a monoclonal antibody currently under review by the FDA for prevention of bleeding in patients who have hemophilia A with coagulation factor VIII inhibitors. Factor VIII is the clotting protein that is deficient in hemophilia A, and inhibitors interfere with factor replacement therapy. Emicizumab was approved by the FDA in November of 2017.Read more
ICER will develop a report on chimeric antigen receptor t-cell (CAR-T) therapies for treatment of B-cell malignancies. ICER’s report will consider the comparative clinical effectiveness and value of tisagenlecleucel (KymriahTM , Novartis) and axicabtagene ciloleucel (YescartaTM, Kite Pharma). Both agents were approved in 2017. Tisagenlecleucel is approved for treatment of relapsed or refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients. Novartis is also expected to file later this year for a second indication for diffuse large B-cell lymphoma in adults. Axicabtagene ciloleucel is approved for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma in adult patients.
Date of Review: March 2018Read more
ICER will develop a report assessing the comparative clinical effectiveness and value of voretigene neparvovec (LuxturnaTM, Spark Therapeutics), a potentially one-time gene therapy for vision loss associated with biallelic RPE65-mediated retinal disease. Voretigene neparvovec is the first gene therapy to be approved by the US Food and Drug Administration (FDA).
Date of review: January 2018Read more
Tardive dyskinesia is a serious and disabling movement disorder that affects individuals treated with antipsychotic agents for a variety of mental health conditions. Though prevention and treatment primarily focus on stopping or changing the offending antipsychotic agent, for some individuals there are no other effective treatment options, and symptoms can persist after discontinuing or changing antipsychotic therapy.
Interventions of Interest:
- Valbenazine (Ingrezza®, Neurocrine Biosciences, Inc)
- Deutetrabenazine (Austedo®, Teva)
- Tetrabenazine (Xenazine®)
Date of Review: December 2017Read more
ICER will develop a report assessing the comparative clinical effectiveness and value of certain non-pharmacologic, non-invasive interventions for chronic low back and neck pain. The report will be the subject of a October 19, 2017 meeting of the California Technology Assessment Forum.
Interventions of Interest:
- Cognitive behavioral therapy
- Tai Chi
Date of review: October 2017Read more
ICER’s report reviews evidence on the comparative clinical effectiveness and value of poly (ADP-ribose) polymerase (PARP) inhibitors for treatment of ovarian cancer.
Interventions of Interest:
- Rucaparib (Rubraca®, Clovis Oncology)
- Niraparib (Zejula®, Tesaro, Inc.)
- Olaparib (Lynparza®, AstraZeneca)